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CERVICAL PLATING SYSTEM
SIGNUS Medizintechnik GmbH · Model Fixation pin · UDI-DI 04047844018828
HXQ
Prescription
0
510(k) clearances
13
Adverse events
1
Recalls
52
Facilities
Description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-09-26 | Biomet, Inc. | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.